I’m in a Drug Study…Sorta

I know how sensitive I am about where/how I get my information about multiple sclerosis. From your comments over the years, I know you are too. Thus, this blog is intended not only as an interesting topic of conversation, but also full disclosure.

I have been asked by the primary investigator of a study funded by the National Institutes of Health (NIH) to act as a patient advocate in the protocol phase of a phase II study looking at neuro-protection in progressive MS. While this study is of a medication (a medication I don’t remember the name of and, quite frankly, don’t even care that much), it’s not the drug part of the study which interests me.

I’d like you to understand my involvement in this study so you can understand why I am excited.

First (and this would have been a non-starter for me), this study is being paid for and all data will belong to NIH — not the drug company. Second, while my statement of not caring about the MS medication may be confusing, this study will help lay down some of the first benchmarks (measures of success, if you will) for treating progressive forms (primary progressive and secondary progressive) of multiple sclerosis. THAT, my friends, is why I was excited to be asked!

The roll of a patient advocate for this study was requested by NIH. The reason: some of the proposed benchmarks are more difficult to ascertain than those used to measure success in relapsing forms of MS.

In relapsing MS, Gadolinium-enhancing lesions which show up on MRI scans indicate inflammation. Inflammation = disease activity. Stop the new lesions, stop the activity. That’s how most of the drugs are measured for success.

In setting up benchmarks for this trial, there are several measures that must be looked at, some of them not the most pleasant. That’s why they’ve asked for a patient to have a look at the plan. Also, as this is an oral drug, there are issues that many researchers just don’t think about when it comes to progressive MS…

As this trial will have multiple doses of the drug throughout the day and different doses will be tried, two bottles (two from one, three from the other), five bottles, and blister packs are all options. The cognitive and fine-motor skills necessary to use any one of these options may be difficult for someone with progressive MS.

Is a brain MRI enough for this trial, or should we do brain and spine? Which part of the spine? The whole spine? If it’s just a brain MRI, will we have enough data? If we scan the whole spine, is that too long in an MRI tube? Are there enough people with progressive MS willing to sign up to be studied? How will prospective subjects react to the idea of lumbar punctures (yup — plural!) as part of the study?

All of these questions (and plenty more) await this team and its nationwide set of research sites (stay tuned for that list). I may, as I have on other occasions, come to you for input. Again, this is an NIH study. They are paying for it, not a drug company. They, not the drug companies, will own the data. The data will be public and available to all (once it is published by the investigators).

Also, I want to ensure that everyone knows that this is an unpaid, 100 percent volunteer position. I will receive nothing for the work. That would have been a non-starter, too.

I know this may be a bit dry for a Monday topic on our blog. I thought, however, that it was important (at least to me) that you are all aware of my involvement.

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ABOUT THE AUTHOR

Trevis Gleason

Trevis L. Gleason is a food journalist and published author, an award-winning chef and culinary instructor who has taught at institutions such as Cornell University, New England Culinary Institute and...read more